The federal agency also removed the maximally tolerated qualifier for statin use and the prior cardiovascular morbidity and mortality limitation of use statement.
The FDA approved an updated indication for Esperion’s bempedoic acid tablet (Nexletol) and bempedoic acid and ezetimibe tablet (Nexlizet) to include treatment of primary hyperlipidemia as a qualifier for existing approved populations, the pharmaceutical company announced in a press release.1
In addition to the updated indication, the federal agency also removed the maximally tolerated qualifier for statin use, as well as the prior limitation of use which said, “the effect of Nexlizet or Nexletol on cardiovascular morbidity and mortality has not been determined.” The update, which is effective immediately, is the result of the FDA’s efforts to modernize and synchronize drug labels.
Esperion submitted both Supplemental New Drug Applications for Nexletol and Nexlizet to the FDA in June.2 The submissions were based off the Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial (NCT02993406). The randomized, double-blind, placebo-controlled study assessed if treatment with bempedoic acid decreased the risk of cardiovascular events in patients who are statin intolerant.
The study, which included nearly 14000 patients, showed that Nexletol demonstrated significant reduction in several major adverse cardiovascular events, including a 27% risk reduction of non-fatal myocardial infarction, a 19% risk reduction of coronary revascularization, and a 23% risk reduction of the composite of fatal and non-fatal myocardial infarction.3
“We are pleased that the FDA has approved these modifications to our current indications for Nexletol and Nexlizet, which reinforce the proven efficacy and safety of these treatments,” Sheldon Koenig, president and CEO of Esperion, said in a release.1
The FDA initially approved Nexletol and Nexlizet tablets in February 2020 as an adjunct to diet and statin therapy for the treatment of primary hyperlipidemia in adults with heterozygous familial hypercholesterolemia, or atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein cholesterol (LDL-C).
Nexletol, a first-in-class ATP Citrate Lyase inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver, was the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002. Nexlizet, which contains bempedoic acid and ezetimibe, lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine.
“Since the announcement of the CLEAR Outcomes results, we’ve seen accelerating adoption of our practice-changing treatments as prescribers, patients and payers alike recognize Nexletol and Nexlizet as the clear next step after statins, and value their potential to significantly reduce cardiovascular risk,” Koenig said in a release.2